FORE Biotherapeutics is a registration-stage targeted oncology company whose lead asset is plixorafenib (FORE8394; formerly PLX8394), a BRAF inhibitor with a mechanism described as both a dimer and paradox breaker. The company is advancing plixorafenib in the global Phase 2 FORTE Master Protocol, a registration-intended basket study that includes monotherapy baskets for recurrent or progressive BRAF V600E primary CNS tumors, rare BRAF V600 mutated solid tumors, and advanced solid tumors with BRAF fusions. Fore reported that target enrollment of approximately 50 patients has been reached in the BRAF V600E CNS tumor basket and expects topline results from that basket around the end of 2026; the company anticipates a potential regulatory submission if the primary analysis is positive. Plixorafenib received Breakthrough Therapy Designation from the FDA in April 2026, and prior Phase 1/2 data showed a 67% ORR in MAPK inhibitor–naïve BRAF V600 primary recurrent CNS tumors (n=9) and a 42% response rate with a median duration of response of 17.8 months in V600-altered, MAPK inhibitor–naïve patients. The company reported a favorable safety profile for plixorafenib, including a drug-related discontinuation rate of less than 2%, and has implemented protocol changes in FORTE such as allowing dosing with food and lowering the minimum enrollment age to 8 years based on IDMC clearance.

Total raised

$186M

Funding rounds

4

Latest round

Series D

Latest activity

Jul 2026